Furious Seasons

January 12, 2009

Report: FDA Screening Of Drug Trials' Scientists Financial Conflicts Is Unreliable

That's the conclusion of a report out today from the HHS Office of the Inspector General (pdf here). From the AP:

"'We found a number of limitations in FDA's oversight, leaving FDA unable to determine whether (drug companies) submit financial information for all clinical investigators,' the report said....
"In all, 42 percent of the applications lacked complete financial information and less than 1 percent of researchers disclosed possible conflicts. Such limitations 'could result in FDA being unaware of a clinical investigator's financial interest, and thus unable to gauge its potential bias on clinical trial results,' the report said."

It confuses the hell out of me that the FDA lets this go on and doesn't go back to the drug companies and investigators and demand proper financial disclosures before a drug is approved. I'd love to get the FDA's view on why this is the case, but as I've learned recently, it's next to impossible to get the simplest of answers out of the FDA concerning some of the simplest aspects of its regulations.

Posted by Philip Dawdy at January 12, 2009 12:19 PM

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Comments

The FDA is a total wreck, according to Rep. Bart Stupak, and I agree. But I did see a piece in the Wash. Post today that said that Dr. Scharfstein, a pediatrician who runs the Baltimore Public Health Department and who used to work for Rep. Waxman, is definitely in the running to head the FDA. This is very good news. In fact, it's about the only good news that's come out of the FDA in many years.

Posted by: Sorrowful at January 12, 2009 12:33 PM

Seriously.

Posted by: Marissa at January 12, 2009 01:47 PM

The FDA isn't the only Federal agency that's broken. Katrina was the tip of the train wreck that is our government.

I have never in my almost 61 years, much of it spent working for government, seen such general incompetence. The level of ineptitude and corruption in the Bush administration has frightened me far more than any terrorist. All pols appoint friends, backers and acquaintances once they get into office. But the Shrub appears to travel in circles that reward incompetence at a level I've never seen, except perhaps in a Wodehouse story.

Sherry

Posted by: Sherry at January 12, 2009 02:12 PM